A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy (ATHENA)

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Blinded independent central review (BICR) PFS [ Time Frame: Every ~12 weeks after the start of combination treatment for ~3 years, then every ~24 weeks thereafter until disease progression. Study data collection expected to last for ~7 years ]

Overall Survival (OS) [ Time Frame: From enrollment to primary study completion of study (up to approximately 10 years) ]

Objective response rate (ORR) [ Time Frame: For patients with measurable disease, every ~12 weeks after the start of combination treatment for ~3 years, then every ~24 weeks thereafter until disease progression. Study data collection expected to last for ~7 years ]

Duration of response (DOR) [ Time Frame: For patients with measurable disease, every ~12 weeks after the start of combination treatment for ~3 years, then every ~24 weeks thereafter until disease progression. Study data collection expected to last for ~7 years ]

Number of participants with treatment-emergent Adverse Events (AEs) as assessed by CTCAE v4 (or higher) as a measure of safety and tolerability [ Time Frame: Collected from the time patient receives first dose of study drug until post treatment safety follow-up period (up to approximately 10 years) ]

Number of participants with serious AEs as a measure of safety and tolerability [ Time Frame: Collected from the time patient receives first dose of study drug until post treatment safety follow-up period (up to approximately 10 years) ]

Number of participants with laboratory abnormalities as a measure of safety and tolerability [ Time Frame: Collected from the time patient receives first dose of study drug until post treatment safety follow-up period (up to approximately 10 years) ]

Original Secondary Outcome Measures ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ICMJE

A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy

Completed cytoreductive surgery, including at least a bilateral salpingo-oophorectomy and partial omentectomy, either prior to chemotherapy (primary surgery) or following neoadjuvant chemotherapy (interval debulking)

Completed first-line platinum-based chemotherapy and surgery with a response, in the opinion of the Investigator

Sufficient tumor tissue for planned analysis

ECOG performance status of 0 or 1

Exclusion Criteria:

Pure sarcomas or borderline tumors or mucinous tumors

Active second malignancy

Known central nervous system brain metastases

Any prior treatment for ovarian cancer, other than the first-line platinum regimen